Simplifying safety reporting as part of clinical trial investigator retention 

The pharmaceutical industry is like many others today in that there is a high turnover rate. The surge in new clinical trials starting and post-pandemic changes in hiring amplify these concerns for clinical investigators. For example, a 2017 study using the FDA’s Bioresearch Monitoring Information system classified 54.2% of principal investigators as “one-and-done,” meaning they had only ever worked on one clinical trial and were likely not interested in participating in another. That study surveyed 201 principal investigators (PIs).

The 2017 survey also identified several factors that affect PIs’ decisions to conduct only a single FDA-regulated drug trial. Some 28.9% of the PIs decided, for personal reasons, not to conduct another trial. A total of 44.4% showed interest in participating in another trial but indicated that no opportunities were available.

The same study identified three categories of broad barriers as generally burdensome or challenging by the majority of investigators polled:

• 63.8% cited workload balance (balancing trial implementation with other work obligations and opportunities)
• 63.4% cited time requirements (time to initiate and implement trial; investigator and staff time)
• 56.5% cited data and safety reporting

Considering that investigator knowledge and experience can directly affect the quality, efficiency, cost and success of clinical trials, it is imperative to identify and improve underlying reasons for these high turnover rates among principal investigators.

The findings illuminate the challenges in finding highly qualified clinicians to perform these important clinical trials. A mechanism to match interested investigators with research sponsors is needed to solve the challenge of finding relevant opportunities. But more importantly, the workload and the complexity of additional tasks that come with participation in a clinical trial must be reduced to motivate PIs and their study teams to continuously participate in clinical trials.

Technology can assist in solving some of the data and safety reporting concerns. By automating these time-consuming reporting obligations, clinicians can focus on working with patients and performing higher-level tasks, supporting efforts to enhance investigator retention turnover by targeting issues that have been identified as problem areas.

Putting the focus on data and safety reporting

Technology is often positioned as the answer to all problems, and it can, of course, often bring significant benefits. However, when looking at the needs of site staff, including investigators, and how their focus should be on the patients, it can be that the introduction of new software systems creates more friction within a process and increases complications for the sites. Therefore, implementing new technology must reduce time, effort and thus cost for both the sponsor and the site with automation.

Key Takeaways Have one centralized location for safety information -> reduced training time and effort, reduced maintenance Reduce effort and cost for sponsor and site The system must be able to allow delegation of tasks to site staff to relieve

A survey conducted by the Clinical Trials Transformation Initiative (CTTI), a public/private partnership, weighed in on clinical trial management. The survey identified that “investigators and research staff believe electronic portals have the potential to increase the efficiency of expedited safety reporting to research sites, but in practice are difficult to use and add to the complexity of the system.”

Safety Letters are typically placed by the sponsor in a standalone study portal, which requires the site teams to be trained for these new systems and then keeps track of the user accesses for each of the different tools. This strategy is not adding any value to the work done by the site and becomes a reason not to look at the safety alerts in a timely manner. Such reminders overwhelm the site further, and this spiral of notifications becomes a point of frustration. Therefore, the access to safety letter portals must be simplified and summarized across studies to reduce the effort of maintaining training records and user access for study teams. This extends further when considering cross-study reporting.

Simplifying reporting systems

Summarizing emails to combine safety notifications for multiple studies can be one way to reduce email traffic and increase the overall efficiency in safety letter distribution and receipt. For example, suppose a site is working on multiple studies. In that case, the software involved in the safety letter notification process must handle the required acknowledgment actions across these studies elegantly.

If the site is expected to manually do this in each study, it again becomes an onerous activity, which becomes error-prone and a barrier to smooth working and retention.

Considering that active multi-trial investigators, according to additional published research, emphasize the importance of a functioning team to be successful in clinical research, any tool dealing with automation should allow and document fulfillment of delegated PI obligations through delegate team members. A transparent view of document status via an intuitive and descriptive central dashboard, which provides all study team members with a real-time overview, can dramatically reduce the workload across the team and simplify communications in this area.

Depending on their local infrastructure and regulations, sites will expect to receive information according to their preferred method. This could mean that they expect courier deliveries, emails with attachments and secure links, even faxes. Any systems supporting them must have this flexibility to ensure strong adoption and a unified view of compliance for the sponsor so that regardless of distribution method, the transparent oversight of activity remains.

An automated system can also provide complete audit trails combined with alert mechanisms to enable full compliance, alleviating additional pressure from PIs.

In summary

Research indicates that PIs are generally frustrated with workloads and time constraints in addition to safety reporting issues. An automated and intuitive dashboard can greatly relieve the safety reporting conundrum and thus have a significant impact on streamlining efficiencies throughout the trial process. In addition, with one centralized location for safety information, training time and maintenance are reduced. At the same time, compliance and cost savings for the sponsor and at the sites are enhanced.

Johanna Koddebusch is a senior business analyst at Pharmasol.